URESIL, LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1450395	1450395	URESIL, LLC	1	N	2027-01-01	5418 WEST TOUHY AVE. SKOKIE IL US 60077

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00817640020486	Ulti-Flo General Purpose Drainage Catheter - HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 14F	1-800-538-7374	sales@uresil.com
00817640020493	Ulti-Flo General Purpose Drainage Catheter - HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 16F	1-800-538-7374	sales@uresil.com
H862TC6000	Gravity Drainage Bag - Optimus 600 Gravity Drainage Bag w/20" I.T.	1-800-538-7374	SALES@URESIL.COM
H862TIVCNC0	Tru-Incise Valvulotome with Interchangeable Heads - Tru-Incise Valvulotome Catheter Kit	1-800-538-7374	sales@uresil.com
H862TIVH20NC0	Tru-Incise Valvulotome with Interchangeable Heads - Tru-Incise 2mm Cutting Head	1-800-538-7374	sales@uresil.com
H862TIVH30NC0	Tru-Incise Valvulotome with Interchangeable Heads - Tru-Incise 3mm Cutting Head	1-800-538-7374	sales@uresil.com
H862TIVH40NC0	Tru-Incise Valvulotome with Interchangeable Heads - Tru-Incise 4mm Cutting Head	1-800-538-7374	sales@uresil.com
H862TIVK2030NC0	Tru-Incise Valvulotome with Interchangeable Heads - Tru-Incise Valvulotome	1-800-538-7374	sales@uresil.com

uresil.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
15984	1180595638	K980889	URESIL NEPHRO-URETERAL STENT	LJE	1998-04-08
15984	2015502024	K930011	URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS	MGZ	1993-05-26
15984	1609709757	K923096	URESIL BILLIARY CATHETER	FGE	1993-07-13
15984	1415959691
15984	1643415217
15984	1648839924
15984	1716385999
15984	1723468073
15984	1785115564
15984	1844062062

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LJE	1	1998-04-08
FGE	1	1993-07-13
MGZ	1	1993-05-26

PMN#

URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK
2010-02-23
URESIL, LLC
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
2005-12-20
URESIL, LLC
MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
2004-08-19
URESIL, LLC

GUDID#

Tru-Incise Valvulotome with Interchangeable Heads - Tru-Incise Valvulotome Catheter Kit
URESIL, LLC
2019-09-17
Tru-Incise Valvulotome with Interchangeable Heads - Tru-Incise 2mm Cutting Head
URESIL, LLC
2019-09-17
Tru-Incise Valvulotome with Interchangeable Heads - Tru-Incise 3mm Cutting Head
URESIL, LLC
2019-09-17
Tru-Incise Valvulotome with Interchangeable Heads - Tru-Incise 4mm Cutting Head
URESIL, LLC
2019-09-11
Tru-Incise Valvulotome with Interchangeable Heads - Tru-Incise Valvulotome
URESIL, LLC
2019-09-11
Gravity Drainage Bag - Optimus 600 Gravity Drainage Bag w/20" I.T.
URESIL, LLC
2017-09-11
Ulti-Flo General Purpose Drainage Catheter - HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 14F
URESIL, LLC
2022-04-27
Ulti-Flo General Purpose Drainage Catheter - HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 16F
URESIL, LLC
2022-04-27
GP General Purpose Drainage Catheter - HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 6F
URESIL, LLC
2022-04-27
Ulti-Flo General Purpose Drainage Catheter - HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 14F
URESIL, LLC
2022-04-28
Ulti-Flo General Purpose Drainage Catheter - HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 16F
URESIL, LLC
2022-04-28
GP General Purpose Drainage Catheter - HYDROPHILIC COATED GP LOCKING CATHETER WITH DEPTH MARKS, 6F
URESIL, LLC
2022-04-27
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 22 cm Pig-to-Pig
URESIL, LLC
2022-04-28
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 24 cm Pig-to-Pig
URESIL, LLC
2022-04-28
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 26 cm Pig-to-Pig
URESIL, LLC
2022-04-28
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 28 cm Pig-to-Pig
URESIL, LLC
2022-04-28
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 22 cm Pig-to-Pig
URESIL, LLC
2022-04-28
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 24 cm Pig-to-Pig
URESIL, LLC
2022-04-28
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 26 cm Pig-to-Pig
URESIL, LLC
2022-04-28
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 28 cm Pig-to-Pig
URESIL, LLC
2022-04-28
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 22 cm Pig-to-Pig
URESIL, LLC
2022-04-29
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 24 cm Pig-to-Pig
URESIL, LLC
2022-04-29
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 26 cm Pig-to-Pig
URESIL, LLC
2022-04-29
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 28 cm Pig-to-Pig
URESIL, LLC
2022-04-29
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 22 cm Pig-to-Pig
URESIL, LLC
2022-04-29
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 24 cm Pig-to-Pig
URESIL, LLC
2022-04-29
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 26 cm Pig-to-Pig
URESIL, LLC
2022-04-29
Nephro-Stent Nephroureteral Stent Catheter - HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 28 cm Pig-to-Pig
URESIL, LLC
2022-04-29
Thora-Vent Thoracic Vent - Insertion Cannula for TV11-13
URESIL, LLC
2022-06-02
Tru-Fix Catheter Fixation Kit - Tru-Fix Catheter Fixation Kit - 6F
URESIL, LLC
2016-08-31
Tru-Fix Catheter Fixation Kit - Tru-Fix Catheter Fixation Kit - 8F
URESIL, LLC
2016-08-31
Tru-Fix Catheter Fixation Kit - Tru-Fix Catheter Fixation Kit - 10F
URESIL, LLC
2016-08-31
Tru-Fix Catheter Fixation Kit - Tru-Fix Catheter Fixation Kit - 12F
URESIL, LLC
2016-08-31
Tru-Fix Catheter Fixation Kit - Tru-Fix Catheter Fixation Kit - 14F
URESIL, LLC
2016-08-31
Tru-Fix Catheter Fixation Kit - Tru-Fix Catheter Fixation Kit - 16F
URESIL, LLC
2016-08-31
Thora-Vent Thoracic Vent - THORA-VENT Suction Tubing Set
URESIL, LLC
2016-09-07
Gravity Drainage Bag - Optimus 600 Gravity Drainage Bag w/36" I.T.
URESIL, LLC
2017-09-11
Tru-Fix Catheter Fixation Kit - Tru-Fix Fixation Dressing Replacement
URESIL, LLC
2016-08-31
Tru-Fix Catheter Fixation Kit - Tru-Fix Fixation Dressing Replacement
URESIL, LLC
2022-05-12
Tru-Fix Catheter Fixation Kit - Tru-Fix Catheter Fixation Kit - 6F
URESIL, LLC
2022-05-12

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